To assess the efficacy and safety of maintenance therapy with ribavirin
alone in chronic hepatitis C, 108 patients were treated with the combination
of interferon alfa and ribavirin for 24 weeks; those who failed to have
a virologic response were offered enrollment in a randomized, double-blind,
controlled trial of ribavirin (1,000-1,200 mg daily) versus placebo for
the subsequent 48 weeks. Patients were monitored at regular intervals
with symptom questionnaires, serum aminotransferase levels, hepatitis
C virus (HCV) RNA levels, and complete blood counts and underwent liver
biopsy at the completion of therapy. Among 108 patients, 50 were still
HCV RNA positive after 24 weeks of treatment, of whom 34 agreed to be
randomized to continue either ribavirin monotherapy or placebo. Among
17 patients who received placebo, there was no overall improvement in
symptoms, serum alanine aminotransferase (ALT) levels, HCV RNA levels,
or hepatic histology. Among the 17 patients who received ribavirin, serum
ALT levels and necroinflammatory features of liver histology were improved,
whereas symptoms, HCV RNA levels, and hepatic fibrosis scores were not
changed significantly from baseline. Responses to ribavirin seemed to
be categorical, such that 8 patients (47%) had definite improvement in
liver histology. Patients with improved histology had improvements in
serum ALT levels both on combination therapy and after switching to ribavirin
monotherapy. In conclusion, continuation of ribavirin monotherapy may
maintain serum biochemical improvements that occur during interferon-ribavirin
combination therapy in some patients and that these improvements are often
associated with decreases in necroinflammatory changes in the liver. Whether
these improvements will ultimately result in prevention of progression
of hepatitis C requires further study.